Welcome to your September 2020 Digital Edition of Medical Design Briefs and Medical Manufacturing & Machining Medical Design Briefs Medical Manufacturing & Machining www.medicaldesignbriefs.com September 2020 September 2020 Maximizing Throughput, Speed, and Efficiency with Robotics Developing a Path for Package Testing Preparing for the UDI Adapting PPE Testing for COVID-19 Plasma Surface Treatment for Diagnostics Medical Manufacturing & Machining SPECIAL SECTION: SPECIAL SECTION: Technology Leaders Technology Leaders Low Latency Manufacturing in Electronics in Electronics for Medical Device Packaging COVID-19: Increasing Ventilator Display Mount Production Supplement to Medical Design Briefs From the Publishers of Click Here Click Here How to Navigate the Magazine: At the bottom of each page, you will see a navigation bar with the following buttons: Arrows: Click on the right or left facing arrow to turn the page forward or backward. Introduction: Click on this icon to quickly turn to this page. Cover: Click on this icon to quickly turn to the front cover. Table of Contents: Click on this icon to quickly turn to the table of contents. Zoom In: Click on this magnifying glass icon to zoom in on the page. Zoom Out: Click on this magnifying glass icon to zoom out on the page. Find: Click on this icon to search the document. You can also use the standard Acrobat Reader tools to navigate through each magazine. We’ve Added More Value-Added To Our Added Value! What, the best technology and best service aren’t enough for you? The recognized world leader in medical-grade foot switches (both wireless and cabled) offers you so much more: • FreeRTQFWEVUCORNGUVQSWCNKƂGFDW[GTU • Free consultation • Free customization options to avoid creating new tools • An unprecedented 2-year warranty • 30+ off-the-shelf designs that satisfy most medical requirements • 'CUKGTYKTGNGUUKPVGITCVKQPVJCPMUVQEGTVKƂECVKQPCPFVGUVTGRQTVU • Important documentation package services for wireless, for example: - Risk Management Plan/Report 2TGRCTCVKQPQHEQPHQTOKV[ƂNGUVTCEGCDKNKV[OCVTKZ(/'#TKUMCPCN[UKUGVE - Meets the requirements of software safety class C (per EN 62304) With all these advantages, why not give us a try? www.steutemeditech.com/worldclasswireless Direct Contact: Maurizio Lauria, Brand Manager 203.244.6302/[email protected] MKF 2 SW2.4LE-MED GP211 www.medicaldesignbriefs.com September 2020 Developing a Path for Package Testing Preparing for the UDI Adapting PPE Testing forYLKLÄUPUN[OLSPTP[Z COVID-19 VML_[Y\ZPVU[LJOUVSVN` Plasma Surface Treatment for Diagnostics Medical Manufacturing & Machining SPECIAL SECTION: SPECIAL SECTION: Technology Leaders Technology Leaders in Electronics in Electronics www.microspecorporation.com 327 JAFFREY RD ࠮ PETERBOROUGH, NH 03458 ࠮ USA +1 603-924-4300 ࠮ [email protected] the Publishers of YLKLÄUPUN[OL SPTP[ZVML_[Y\ZPVU [LJOUVSVN` ࠮5,>*65*,7;: ࠮:05.3, 4<3;03<4,5;<)05. ࠮)<47;<)05. ࠮*6,?;9<:065: ࠮40*96,?;9<:065: ࠮796-03,,?;9<:065: ࠮*6(;,+>09, ࠮;90,?;9<:065: ࠮4<3;03(@,9,+,?;9<:065: ࠮-<33@,5*(7:<3(;,+:;907,: ࠮6=,9,?;9<:065: ࠮)(33665;<)05. ࠮05;,940;;,5;4<3;0+<964,;,9,?;9<:065: ࠮90))65,?;9<:065: www.microspecorporation.com 1(--9,@9+ 7,;,9)696<./5/࠮<:( [email protected] 13485 Free Info at http://info.hotims.com/76507-732 www.medicaldesignbriefs.com September 2020 Developing a Path for Package Testing Preparing for the UDI Adapting PPE Testing for COVID-19 Plasma Surface Treatment for Diagnostics Medical Manufacturing & Machining SPECIAL SECTION: SPECIAL SECTION: Technology Leaders Technology Leaders in Electronics in Electronics From the Publishers of NEW GENERATION You’ve never seen a solenoid valve like this before. ® High Flow, Low Power, Low Leakage Across an Extensive Cycle Life The Lee Company is excited to announce a new generation of versatile and innovative 3-port solenoid valves. In a miniature 10mm package, the genvi® solenoid valve platform features high flow capacity, low leakage and ultra-low power consumption. Designed using innovative manufacturing techniques, this new valve offers not only unmatched reliability, but also an economical price point suitable for molecular diagnostics, respiratory therapy, compression therapy, environmental monitors, breath analyzers and other applications where performance and reliability are paramount. When designing portable or stationary instruments, OEMs are often challenged with meeting aggressive size, power, and weight limitations, all without sacrificing the remaining elements of system-level performance. Each subcomponent is therefore pushed to offer improved performance within a smaller footprint. Featuring high flow and low power consumption, genvi solenoid valves are the solution. An extremely tight leakage rating reduces compressor demand and further underscores the valve’s ability to provide consistent long-term operation across an extensive cycle life. Custom valve solutions, supported by The Lee Company’s Innovation in MiniatureÊ engineering experience in microfluidics, are also available ® to meet specific application requirements. The Lee Company 2 Pettipaug Rd Westbrook CT 06498-0424 860-399-6281 | 1-800-LEE-PLUG www.theleeco.com W E S T B R O O K • L O N D O N • P A R I S • F R A N K F U R T • M I L A N • S T O C K H O L M Free Info at http://info.hotims.com/76507-733 1 1/8/20 3:48 PM MADE IN THE U.S.A. Interpower® North American & International Hospital-Grade Cords With 1-Week U.S. manufacturing Lead-Times on non-stock • Quantity price breaks available with Interpower products, and Same Day Shipping on in-stock blanket or scheduled orders products, reliable power is readily available to critical medical facility patients, families and staff. Whether a city hospital or a • No minimum order or dollar country clinic, Interpower manufactures hospital-grade power requirements cords and cord sets to hospital-grade specifications and ships • Value-added options, e.g., colors, them on time! lengths, packaging and labeling When designing, building, and maintaining hospital-grade products to be used worldwide, it is important to know the medical requirements of the country of export. In addition, select Resource Links: hospitals have proprietary requirements. Special consideration is needed for products used in Australia, Canada, Denmark, Japan, Interpower Shipping __ and the United States. Product Info Questions? Interpower offers free technical support to both beginners and experts to help you find exactly what you need. Guides and Charts White Papers ® Order Online! ® www.interpower.com Business Hours: 7 a.m.–6 p.m. Central Time INTERPOWER | P.O. Box 115 | 100 Interpower Ave | Oskaloosa, IA 52577 | Toll-Free Phone: (800) 662-2290 | Toll-Free Fax: (800) 645-5360 | [email protected] Free Info at http://info.hotims.com/76507-734 September 2020 Published by Tech Briefs Media Group, an SAE International Company COLUMN SPECIAL SECTION 4 From the Editor Technology Leaders in Electronics 20 Thin Film Electrodes Show Potential for Transforming FEATURES Neurosurgery 8 Medical Device Package Testing: Developing a Test Plan 25 When Every Second Counts … Important Considerations that Avoids Product Launch Delays for Respiratory Ventilator Design 12 Are You Ready for the Next UDI Deadline? 28 How Unlimited-Length Flexible Printed Circuits Are 16 Adapting Under COVID: Expansion and Implementation of Transforming Electrical Interfaces in Medical Devices PPE Testing ON THE COVER TECH BRIEFS Plasma treatments help eliminate air bubbles that can accumulate and thus interfere with the proper mixing of 36 Temporary COVID-Specific Treatment and Testing Facilities reagents. To learn about the role of plasma treatments in Require Distinct Interconnect Solutions modifying the surface of the plastic multi-well cartridges 38 Four Critical Challenges of Prehospital Infusion used in COVID-19 testing, read the article on page 44. (Credit: PVA TePla) 40 New Wearable Sensor Tracks Vitamin C Levels in Sweat 41 Spinal Stimulators Repurposed to Restore Touch in Lost MEDICAL MANUFACTURING & Limb MACHINING (Selected editions only) 42 Robotic Arm Helps Perform Delicate Surgeries 1a Low Latency Manufacturing for Biophotonics and Medical 44 Fast-Tracking Diagnostic Testing for COVID-19 and Other Device Packaging Viruses 6a An Inside Look at Maximizing Throughput, Speed, and Efficiency with Robotics in Medical Device Manufacturing DEPARTMENTS 9a Case Study: Increasing Ventilator Display Mount 34 R&D Roundup Production to Meet COVID-19 Demands 46 New Products & Services 11a New Approach to Fastener Design Prevents 49 Advertisers Index Loosening in Medical Devices 50 Global Innovations 13a Tech Briefs (Credit: Stäubli Tec-Systems GmbH Robotics) 2 Fr ee Inf o at h tt p : //inf o. h ot ims . c o m/76 50 7-7 35 Medical Design Briefs, September 2020 We invented CYROLITE® over 40 years ago – and we’ve used the time ever since to perfect its properties. The result is highly advanced acrylic polymers that boast outstanding optical properties such as superior UV trans- mittance. At the same time, CYROLITE® offers excellent fl ow properties, thus enabling them to be molded into extremely thin-walled components. It goes without saying that CYROLITE® meets all the relevant USP Class VI, ISO 10993-1, and REACH standards. For more So clear it’s like it’s not even reasons why CYROLITE® is the clear choice, here: highly transparent visit www.cyrolite.com. CYROLITE® for diagnostic applications. Free Info at http://info.hotims.com/76507-736 FROM THE EDITOR Device Companies Seek M&A Barometer,